Module 14 2022

22/03/2022

4 common problems to avoid… (according to the US FDA)

1. Ignoring ISO 14971: 2019 ● Reduction of risks “as far as possible” and not ALARP ● Establish risk control measures for ALL risks and not just for those that are unacceptable. ● Perform a risk / benefit analysis for all risks ● Risk reduction must go beyond the information provided to the user. 2. Treating risk management and design controls as distinct processes.

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

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4 common problems to avoid… (according to the US FDA)

3. USING FMEA AS A RISK MANAGEMENT MODEL FOR MEDIAL DEVICES ● This is effective for measuring failure modes and reliability but it doesn’t fully align with ISO 14971. – Use ISO 14971 as the basis of your risk management process

4. Treating risk management as a checklist item ● It’s much broader than that!

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

38

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